• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name calibrator, multi-analyte mixture
510(k) Number K051619
Device Name LIPOPROTEIN FOR MULTIPLE ANALYTES
Original Applicant
BAYER HEALTHCARE, LLC
511 benedict ave.
tarrytown,  NY  10591
Original Contact anders holle
Regulation Number862.1150
Classification Product Code
JIX  
Date Received06/17/2005
Decision Date 08/01/2005
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-